REPORTER'S NOTEBOOK: Dealing with FDA inspectors

07/01/2002

By Mark A. DeSorbo

NEW YORK CITY- The seemingly idle Thursday morning changes dramatically when the receptionist pages you and tells you there are three inspectors from the U.S. Food and Drug Admin is tration (FDA) in the lobby.

You, the quality manager of a medical device manufacturer that employs 1,000 people, waste no time in getting down to the lobby, where the inspectors present you with their credentials and an FDA 482 form-a notice of inspection.

Whether it's convenient or not, the three inspectors have their hearts set on conducting a full evaluation to ensure the plant is adhering to current good manufacturing practices (cGMPs).

They wish to begin with a tour of the facility, and you decide to take them on the tour by yourself because the bosses, the manufacturing manager and two vice presidents, are tied up in a meeting.

The inspectors seem impressed with the thorough and efficient record keeping system in the shipping and receiving department, and the tour moves on to the QA receiving inspection department, which is managed by Mary Doe.

"Well, the receiving department messed up again and misplaced two bins of resin that should have been in quarantine," Mary blurts out before being introduced to the inspectors.

Interest on the parts of the inspectors is now more than piqued, and they begin asking more questions and requesting additional documents that verify the objective evidence they need to form an opinion.

As your group leaves the QA receiving inspection department, you run into Jim, the manufacturing manager, and after introductions are made, Jim recommends that he finishes the tour so that you can pull together the requested standard operating procedures for the manufacturing process and reserve a conference room.

Was this company prepared for an FDA inspection?

"No," say the dozen people who attended Elaine Messa's presentation, "FDA Inspections Made Easy," at a medical device manufacturing tradeshow held here in late June.

The former FDA inspector, who is now vice president of medical device quality systems for Quintiles Consulting (Irvine, CA), engaged a small audience divided into two groups by asking them to answer a series of questions on the surprise inspection.

The breakout session also provided a great deal of insight as to just how some medical industry professionals feel about FDA compliance officers and site inspections.

Most attendees immediately thought the situation, while laughable, could have been handled in a completely different manner, answering question 1 of whether the company was prepared for the inspection with a unified and assertive "no."

Question 2 asked what the company could do in the future to ensure things look and feel like they are in control when the FDA arrives.

"Interrupt the meeting," a man in the group from the front of the room says.

"Management should have been notified immediately that FDA inspectors were on site," adds a man from the second group.

Both groups agree, and Messa indicates the chain of command should have been notified, adding that as an FDA inspector she has arrived to perform inspections and set off alarms.

"I've seen lights go off and heard alarms, alerting employees that I was there," she says. "I've even heard PA announcements like, 'Congratulations! Mary gave birth to twins' as a code that an FDA inspector was on site."

And the attendees definitely liked that idea, saying the inspectors should have been given visitor's badges at the very least.

"Or how about big hats that say 'FDA' on them," another man from the first group says.

That got more than just laughs. From the sounds of it, a few seemed ready to schedule in time to find or design the gaudiest hats possible; any attempt to make the Feds feel the same discomfort they feel on the day of a surprise inspection.

Questions 3, 4 and 6 were somewhat retrospective, asking how a plan may have helped, what information should be included in coordinating an inspection and what else the company could have done to ensure all employees are prepared for FDA inspections.

"Starting with a tour was dumb," a woman in the second group exclaims.

"They belabored the inspection without [a plan]," adds the guy who conceived the idea for a special FDA hat.

All agreed it was a "classic example" of ill preparedness that could have been avoided if a plan was in place: A protocol that includes notifying the chain of command, providing visitor badges and setting up a tour with introductions to "spokespersons for particular areas" of the plant.

The groups also agreed that employees should be trained on the importance of being helpful, friendly, but know what to say and what not to say.

One rather courteous, yet silver-tongued participant, whose knowledge seemed to make him stand out from other attendees, recalled how a co-worker of his was asked by an FDA inspector on whether he had signed off on a series of documents that needed his John Hancock.

The manager, he explains, could not give a definite answer.

"So, after the inspection, I asked him 'What if I put a gun to your head for an answer'," the savvy attendee told his intrigued group members. "He said he'd take the bullet."

Of course Question 5 proved that there was something about Mary, the quality assurance manager who made light of a blunder that could have sent the FDA inspection in a completely different direction.

Could the FDA document the comments Mary made about the missed placed bins of resin?

The groups answered with a unified "yes," and agreed the instance was very compelling in that it would seem this kind of thing has happened before. Some attendees, however, thought that what Mary said was "not verifiable."

One thing is for sure, attendees felt that when FDA inspectors show up, the visit is often regarded as a nuisance that forces the manufacturer to cordially greet their so-called guests when, in fact, they are wishing all the while they could hand the inspectors their proverbial hats and, in the same breath, ask what their hurry is.

"There's nothing more important than getting those people out of there," the seemingly insightful attendee added in a departure from his poignant manner.

"Yeah," another says. "You got that right."